Packaging assembly for storing tissue and cellular material

Abstract

The invention is an improved packaging assembly for storing, distributing, treating, mixing, and dispensing tissue and/or cellular material and/or implantable material. The packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material that is open at one end and a needle-free swabable connector attached to the pouch at the other end and acting as a port to allow for the introduction or discharge of biological solutions, rinsing solution, and/or preservation solutions into the packaging assembly. The designed thickness of the wall of the packaging assembly facilitates efficient heat/cold transfer, which is useful for successful controlled rate freezing, quick thawing, and resuscitation of viable cells or tissue. The invention is also useful for combining additional biological fluids with the cellular material or tissue, and for efficient mixing of the biological fluids with the tissue and/or cellular material in the assembly.

What is claimed: 
     
       1. A kit for storing disinfected tissue and/or cellular material comprising:
 a pouch made of a flexible polymeric material, the pouch having a first opening that is configured to be sealed and cut via an incision, and a second opening opposite the first opening and attached to a needle-free swabable connector; 
 the pouch having a single compartment, the single compartment containing:
 a tissue and/or cellular material selected from the group consisting of cortical bone chips, cancellous bone chips, and corticocancellous bone chips, wherein the bone chips comprise viable bone lineage committed cells, the tissue and/or cellular material mixed in a cryopreservation solution and packaged within the single compartment; 
 
 wherein the connector is configured to act as a port to allow for the introduction and discharge of biological solutions, rinsing solutions or the cryopreservation solution into and from the pouch without removal of the tissue and/or cellular material from the pouch through the port; and 
 wherein the pouch is designed to facilitate delivery of the tissue and/or cellular material via the incision of the pouch. 
 
     
     
       2. The kit of  claim 1 , wherein the polymeric material has a wall thickness of between about 0.003 inches and about 0.006 inches. 
     
     
       3. The kit of  claim 1 , wherein the polymeric material is selected from the group consisting of fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), perfluoroalkoxy polymer resin (PFA), Ethylene tetrafluoroethylene (ETFE), Polyetheretherketone (PEEK), Polyvinylchloride (PVC), Polyethersulfone (PES), Polyethylene (PE, of various types), Polyurethane (PU), Polyetherimide, PEI, Cyclic Olefin Copolymer (COC), Polycarbonate (PC), Polysulfone (PS), Polypropylene (PP), BPA free polyester, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polyesters, polyamides, polypropylenes, polyurethanes, and polyvinylidenefluoride. 
     
     
       4. The kit of  claim 1 , wherein the connector further comprises a luer lock adapter. 
     
     
       5. The kit of  claim 1 , further comprising one or more of:
 saline, glycerol, hyaluronic acids, alginate, chitosan, lactated ringers, lactated ringers containing dextrose, serum, serum albumin, dimethyl sulfoxide, glucose, trehalose, vitamins, culture media, plasma, platelet rich plasma, platelet poor plasma and cryopreservation media and mixtures thereof. 
 
     
     
       6. The kit of  claim 1 , further comprising at least one additional needle-free swabable connector located on the pouch. 
     
     
       7. The kit of  claim 1 , further comprising a secondary container, wherein the sealed pouch is placed in the secondary container. 
     
     
       8. The kit of  claim 1 , wherein the bone chips comprise cancellous bone. 
     
     
       9. The kit of  claim 1 , wherein the bone chips comprise corticocancellous bone. 
     
     
       10. The kit of  claim 1 , wherein the bone chips comprise cortical bone. 
     
     
       11. The kit of  claim 1 , further comprising demineralized cortical bone matrix, wherein the demineralized cortical bone matrix comprises bone fibers, bone particles or mixtures thereof. 
     
     
       12. The kit of  claim 1 , further comprising demineralized cortical bone fibers. 
     
     
       13. The kit of  claim 1 , further comprising demineralized cortical bone particles. 
     
     
       14. The kit of  claim 8 , further comprising demineralized cortical bone fibers. 
     
     
       15. The kit of  claim 9 , further comprising demineralized cortical bone fibers. 
     
     
       16. The kit of  claim 10 , further comprising demineralized cortical bone fibers. 
     
     
       17. The kit of  claim 8 , further comprising demineralized cortical bone particles. 
     
     
       18. The kit of  claim 9 , further comprising demineralized cortical bone particles. 
     
     
       19. The kit of  claim 10 , further comprising demineralized cortical bone particles. 
     
     
       20. The kit of  claim 1 , wherein the solutions comprise plasma, blood, bone aspirate, serum albumin or mixtures thereof. 
     
     
       21. The kit of  claim 1 , further comprising soft tissue, cartilage, tissue derived material, synthetic biomaterial, engineered biomaterial, natural polymers, human cellular material, animal cellular material, stem cellular material, differentiated cellular material and mixtures thereof. 
     
     
       22. The kit of  claim 1 , wherein the cryopreservation solutions comprise saline, glycerol, hyaluronic acids, alginate, chitosan, lactated ringers, lactated ringers containing dextrose, serum, serum albumin, dimethyl sulfoxide, glucose, trehalose, vitamins, culture media, plasma, and mixtures thereof.